Third Molar Extraction
Conditions
Keywords
Third Molar Extraction, Alveolar Bone Regeneration
Brief summary
Distal bone loss of the second molar due to extraction of the third molar is one of the most common pathological conditions that results in tooth loss of second molar. However, regeneration of functional alveolar bone has proved difficult. Therefore, the investigators conduct a two-arm study to evaluate the efficacy and safety of alveolar bone regeneration induced by gelatin sponge-loaded apoptotic vesicle complex in patients with mandibular third molar extraction.
Detailed description
This study is a single-center, prospective, two-arm study to evaluate the efficacy and safety of alveolar bone regeneration induced by gelatin sponge-loaded apoptotic vesicle complex in patients with mandibular third molar extraction. This study plans to include 30 subjects from the Department of Stomatology of the Fifth Affiliated Hospital of Guangzhou Medical University. One socket for each participant in this study will receive gelatin sponge-loaded apoptotic vesicle complex after third molar extraction and socket debridement. The other side of socket for each participant in this study will receive commercial gelatin sponge after the same surgery. All participants will undergo screening and baseline visits. After surgery, the participants will be followed up for 1 year.
Interventions
DRUGGelatin sponge-loaded apoptotic vesicle complex（Kuaikang®)
The experimental group
DRUGGelatin sponge only （Kuaikang®)
The positive control group
Sponsors
Fifth Affiliated Hospital of Guangzhou Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Patients aged 18-45 (including the boundary value) 2. Patients who need to extract the bilateral mandible third molars 3. Patients who voluntarily sign the informed consent form
Exclusion criteria
1. The adjacent second molars in the patient's oral cavity are affected by pulp injury or insufficient endodontic treatment, or show tooth fracture, or have a degree of motion of 3 degrees 2. The adjacent second molars have metal crowns or large amalgam restorations 3. There is an uncontrollable pathological process in the patient's oral cavity 4. Malnutrition (serum albumin concentration \<2 g/dl) 5. Other systemic, infectious diseases and hereditary diseases, or patients in the acute inflammatory phase and acute exacerbation phase of chronic diseases 6. Patients who are pregnant, lactating, or planning to become pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone volume fraction of regenerated bone tissue in the extraction area at 3 months after operation | 3 months | CBCT is a cone-beam projection computerized reconstruction tomography device. Its principle is that the X-ray generator uses a low radiation dose to make a circular DR (digital projection) around the projection body. Then the data obtained in the intersection after digital projection around the projection body multiple times is reconstructed in the computer to obtain a three-dimensional image. CBCT can observe the three-dimensional level of bone regeneration, so as to calculate the bone volume fraction of the regenerated bone tissue. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemostatic time after third molar extraction | 0 day | After the third molar was completely extracted, commercial gelatin sponge or gelatin sponge loaded with apoptotic vesicle complex were placed in the socket. The time to hemostasis in the extraction socket was observed and recorded at the same time. |
Countries
China
Outcome results
None listed